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OpenTrials
Completed

NCT Number: NCT05712005

Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study

An open-label, multi-site, validity and reliability study to obtain data on the Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests to assess scoring and normative ranges and compare against other cognitive tests within a diverse population.

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Key information

Conditions

Cognitive Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Velocity Clinical Research

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Fluent in English
  • Full vision in at least one eye
  • Full use of at least one functional hand
  • In overall good health, not experiencing any acute symptoms
  • Agrees to cognitive examinations administered by research team

Exclusion criteria

  • Age under 18
  • Not fluent in English
  • Blind in both eyes (any level of diagnosed blindness)
  • Lacking a functional hand
  • Those entering or in hospice
  • Inability to agree to cognitive examinations administered by research team

Treatment and study plan

Primary outcomes

  1. Confirmation of scoring and normative ranges.

    Time frame: 4 months

    Confirmation of scoring and normative ranges in Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

Secondary outcomes

  1. Stratify study population by age

    Time frame: 4 months

    Stratify study population by age compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

  2. Stratify study population by sex

    Time frame: 4 months

    Stratify study population by sex compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

  3. Stratify study population by education

    Time frame: 4 months

    Stratify study population by education compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

  4. Stratify study population by ethnicity

    Time frame: 4 months

    Stratify study population by ethnicity compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

  5. Training effect

    Time frame: 4 months

    Determine level of training effect.

  6. Compare test sensitivity

    Time frame: 4 months

    Comparison of test sensitivity between Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests and other cognitive assessment tests including: Reaction Time, Digit Span, Stroop and Visual Go No Go. In addition, RBANS and D-KEFS will be used as Cognitive Validators

Sponsors and collaborators

Lead sponsor

Cognivue, Inc.

Industry

Collaborators

  • Velocity Clinical Research

Registry information

Official study title

Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study (FOCUS)

Acronym: FOCUS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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